Principal Research Associate MS&T DP at Moderna

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

18 Mar, 26

Salary

0.0

Posted On

18 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Formulation, Fill/Finish, Visual Inspection, Packaging, Process Validation, Tech Transfer, Risk Assessments, SOPs, Training Programs, Lean Principles, Six Sigma, Technical Writing, Root Cause Analysis, Communication Skills, Statistical Analysis, Quality Systems

Industry

Biotechnology Research

Description

The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its presence in Melbourne, a city at the forefront of Australia's biotech industry. Our Melbourne office focuses on commercial operations, ensuring the delivery of our innovative products to the Australian market. We're inviting international professionals to join us in our mission of delivering the greatest possible impact to people through mRNA medicines. As a Principal Research Associate, MS&T Drug Product, you will be responsible for establishing Drug Product (DP) MS&T activities at our Clayton, Australia site (MTC-M). Reporting to the MS&T Drug Product Site Lead, you will serve as a technical specialist ensuring robust validation practices, technology transfers, continued process verifications, investigations, and change management in support of a new drug product manufacturing line. Your expertise will drive the development of compliant, high-quality systems and processes critical to delivering mRNA products for local and export markets. As a senior team member, you will champion quality culture and contribute to the site’s technical leadership. Here’s What You’ll Do: Your key responsibilities will be: Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities. Ensure manufacturing alignment with mRNA/LNP platform standards, author and review cGMP documentation. Perform risk assessments, generate SOPs, and establish training programs. Monitor key performance indicators to identify and improve inefficiencies. Support operational metrics, departmental budgets, and site planning. Investigate complex manufacturing issues with cross-functional teams. Act as technical expert for audits and inspections. Collaborate with global sites on data sharing and best practices. Integrate Lean and Six Sigma principles for continuous improvement. Execute technical support for media fills, cleaning verifications, and material qualifications. Your responsibilities will also include: Strict adherence to Good Documentation Practices and Data Integrity. Completing training per assigned learning plans and requalification schedules. Maintaining deep expertise in quality systems, cGMP, and industry standards. Performing additional duties as assigned, including exploring opportunities for integration of Generative AI tools to streamline validation and investigation processes. The key Moderna Mindsets you'll need to succeed in the role: We behave like owners. The solutions we’re building go beyond any job description. As the Principal Research Associate, you will be pivotal in establishing the foundational validation and MS&T operations at a new site, acting with full ownership over your domain and its strategic impact. We digitize everywhere possible using the power of code to maximize our impact on patients. You will actively seek opportunities to integrate digital and AI tools into validation processes, enhancing efficiency, compliance, and data-driven decision-making to optimize patient outcomes. Here’s What You’ll Need (Basic Qualifications): Education: Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field. Experience: A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile manufacturing operations. This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. As part of Moderna’s commitment to workplace health and safety, this role may be subject to pre-employment and periodic medical assessments, in line with relevant legal and operational requirements. Here’s What You’ll Bring to the Table: (Preferred Qualifications) Demonstrated ability to analyze complex issues and situations: Experience in a pharmaceutical manufacturing environment, preferably in a role related to aseptic fill finish process, process optimization, or technical support. Experience with creating and delivering training programs. Familiarity with process validation principles and statistical analysis techniques. Technical writing skills and proficiency in investigations and root cause analysis. Strong communication and presentation skills. Proficiency in English required. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities. Ensure manufacturing alignment with mRNA/LNP platform standards and perform risk assessments.